Development of a Self-Care Measurement Scale for Patients With Inflammatory Bowel Disease (IBD) and Its Application in an Outpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Psychometric Validation of the SC-IBD Scale
研究概览
简要总结
This study aims to develop and validate a disease-specific self-care measurement scale for patients with Inflammatory Bowel Disease (IBD). The research follows a sequential mixed-methods design: a qualitative phase to identify key self-care concepts, followed by a quantitative phase to test the psychometric properties of the newly developed SC-IBD scale in an outpatient population.
详细描述
This study is designed to develop and validate the SC-IBD scale, a disease-specific instrument for measuring self-care in patients with Inflammatory Bowel Disease (IBD). The project uses a sequential exploratory mixed-methods design.
In the qualitative phase, semi-structured interviews will be conducted with outpatients diagnosed with IBD to explore their experiences of self-care across the three theoretical dimensions described in the Middle-Range Theory of Self-Care of Chronic Illness: maintenance, monitoring, and management. The qualitative findings will inform item generation and content validity assessment through a multidisciplinary expert panel.
The quantitative phase will include the administration of the preliminary SC-IBD scale to an outpatient cohort in order to evaluate its psychometric properties, including construct validity, internal consistency, and test-retest reliability. Additional validated instruments (DASS-21, SF-12, BIPQ, IBD-Control, and the Short Food Literacy Questionnaire) will be used to assess convergent and divergent validity and to describe relevant psychological, clinical and behavioral correlates of self-care in IBD.
The ultimate goal of the study is to produce a reliable, valid, and clinically useful tool for assessing self-care behaviors in individuals living with IBD, supporting both research and clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary willingness to participate in the study.
- •Diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) for at least 12 months.
- •Follow-up in outpatient setting.
- •Age 18 years or older.
- •Ability to read and speak Italian.
- •Ability to understand the study procedures.
- •Signed informed consent.
排除标准
- •Age younger than 18 years.
- •Significant cognitive impairment (e.g., dementia) that may limit participation.
- •Insufficient comprehension of the Italian language.
- •Severe psychiatric disorders that may compromise participation.
- •Severe clinical conditions preventing participation in interviews or questionnaire completion.
- •Refusal to sign the informed consent form.
结局指标
主要结局
Psychometric Validation of the SC-IBD Scale
时间窗: Baseline to 3 months
Assessment of the psychometric properties of the SC-IBD scale, including internal consistency (e.g., McDonald's Omega), construct validity (exploratory and confirmatory factor analyses), content validity, convergent and divergent validity, and test-retest reliability. Analyses will determine whether the scale reliably and validly measures self-care behaviors in patients with Inflammatory Bowel Disease.
次要结局
- Qualitative Themes of Self-Care in Patients with IBD(Baseline)
- Psychological Distress Measured by DASS-21(Baseline)
- Health-Related Quality of Life Assessed by SF-12(Baseline)
- Illness Perception Measured by BIPQ(Baseline)
- Perceived Disease Control Measured by IBD-Control(Baseline)
- Food Literacy Assessed by the Short Food Literacy Questionnaire(Baseline)